The present invention relates to a dosage form for hormonal contraception consisting of a specific number of hormone-containing daily units A and of 7-3 hormone-containing daily units B, the hormone component of which in each case consists solely of a gestagen, for uninterrupted daily, oral administration of the hormone-containing daily units A, immediately followed by uninterrupted daily, oral administration of the hormone-containing daily units B to women, characterised in that the hormone-containing daily units A in each case contain folic acid in a daily amount of up to at most 200 μg and the hormone-containing daily units B in each case contain folic acid in a daily amount of more than 200 μg up to the maximum permissible amount of folic acid for women.
Hormonal contraceptives based on a gestagen as the hormone component are known as the gestagen pill.
It is suspected that taking these gestagen-based hormonal contraceptives over an extended period may lead to a deficiency of folic acid. This deficiency may lead to cardiovascular diseases, for example.
It is also known that if pregnancy occurs within a short time after stopping taking such hormonal contraceptives, there is a risk that the deficiency of folic acid may lead to neural tube defects in the embryo. Since the neural tube develops in the first weeks of pregnancy, it is particularly advantageous to ensure that folic acid is taken prior to conception.
If, therefore, a woman stops taking the gestagen pill because she wants to have a child and she falls pregnant in the first cycle after stopping the gestagen pill, it is particularly important to ensure an appropriately large amount of folic acid in the period directly after stopping taking the gestagen pill.
There is therefore a need to provide hormonal contraceptives based on a gestagen as the only hormone component with folic acid in such a manner that the added amount of folic acid is adapted to the variable requirements over the time during a pill-taking cycle and thereafter.
The combination of hormonal contraceptives and folic acid is already known from WO 99/53910. The amount of folic acid per hormonal daily dose is only adapted in accordance with the variable requirement for folic acid according to a woman's advancing age. No account is, however, taken of the variable requirement for folic acid over the pill-taking cycle of a contraceptive.